BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2961239 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00480
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) PINCHED NERVES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HCP REPORTED THE PATIENT EXPERIENCED AN OVERDOSE. THE PATIENT HAD THEIR PUMP REFILLED AND REPROGRAMMED THE DAY PRIOR. THE PATIENT WAS IN THE EMERGENCY ROOM AND WAS "BASICALLY UNCONSCIOUS" AND HER "BLOOD PRESSURE'S DOWN." THE PATIENT RESPONDED TO NARCAN BUT WAS "GOING BACK UNDER." THEY PLANNED TO PUT HER ON A NARCAN DRIP. PATIENT REPORTED THEY WERE SICK AND IN THE HOSPITAL. THEIR PUMP WAS ADJUSTED AND SHE ALMOST DIED. WHEN THE PATIENT WOKE UP SHE HAD A TUBE IN HER THROAT. THE PATIENT SAID SHE WOULD HAVE SCREAMED IF SHE COULD AND TAKEN HER LIFE BASED ON HOW SHE WAS FEELING DUE TO THE ADJUSTMENT. THE PATIENT SAID SHE "HURT SO BAD." PATIENT STATED THE EXPECTED NEXT REFILL DATE WAS THE YEAR 2020 DUE TO THE ADJUSTMENT. PATIENT REQUESTED THAT NO ONE TOUCH HER OR THE PUMP UNLESS IT IS APPROVED BY HER PHYSICIAN. THE PATIENT DIDN'T UNDERSTAND WHY HER PUMP WAS ADJUSTED. THE PATIENT WENT TO THE HOSPITAL INITIALLY BECAUSE SHE HAD PNEUMONIA WHICH SHE GETS DUE TO OTHER MEDICAL ISSUES. THE PATIENT HAD LOST FORTY POUNDS. PATIENT HAD PNEUMONIA THREE TIMES WHILE IN THE HOSPITAL. THE PATIENT HAD BEEN DIAGNOSED WITH PINCHED NERVES IN HER HIP, THE SAME SIDE WHERE THE PUMP WAS LOCATED, WHICH AFFECTS HER VAGINA. THE PUMP WAS DELIVERING PRIALT AND DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION IT WAS REPORTED THAT (B)(6) 2013 THE PATIENT HAD A PUMP ADJUSTMENT DONE BY A HOME HEALTH SERVICE. PRIOR TO THE PUMP TITRATION THE PATIENT'S DOSE WAS 1.66 MCG/DAY. IT WAS UNKNOWN WHAT THE DOSE WAS TITRATED UP TO. THE PATIENT HAD BEEN "GETTING SICK" PRIOR TO THE PUMP ADJUSTMENT. ON (B)(6) 2013 THE PATIENT WAS NOTED TO BE UNRESPONSIVE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH RENAL FAILURE AND PNEUMONIA. THE PATIENT WAS INTUBATED AND ADMITTED TO THE HOSPITAL. SYSTEMIC INFECTION FROM PNEUMONIA WAS NOTED AS A POSSIBLE CAUSE FOR RENAL FAILURE. WHILE HOSPITALIZED THE DOSE WAS DECREASED TO 0.0256 MCG/DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNKNOWN DATE. (B)(6) 2013 THE PATIENT'S DOSE WAS INCREASED TO 0.1971 MCG/DAY, AND THE PATIENT WAS DOING BETTER. THE RENAL FAILURE HAD IMPROVED AND THE PATIENT WAS ASYMPTOMATIC FROM PNEUMONIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LAST REFILL WAS ON (B)(6) 2012. IT WAS NOTED THAT, DURING THIS REFILL, THE RESERVOIR WAS NOT ACCESSED WITHOUT DIFFICULTY AND A TEMPLATE WAS NOT USED; 4ML WAS ASPIRATED AND IT WAS NOTED THAT THIS AMOUNT WAS WITHIN THE 25% VARIANCE. THE PUMP WAS PROGRAMMED TO DELIVER 25MG/ML AT 12.587MG/DAY OF DILAUDID AND 3.3MCG/ML OF PRIALT. THE DAILY DOSE OF PRIALT WAS NOT NOTED. THERE WAS NO CHANGE TO THE PROGRAMMING AND THE PUMP WAS UPDATED VIA TELEMETRY. AT THIS TIME, THE DATE OF ALARM AND NEXT REFILL WAS (B)(6) 2013. AFTER THE REFILL, THE PATIENT STAYED IN THE RECOVERY ROOM FOR OBSERVATION. VITAL SIGNS WERE STABLE. THERE WERE NO NEW SENSORY LOSS AND LEG WEAKNESS BEFORE THE PATIENT WAS DISCHARGED HOME WITH AN ADULT. THE PATIENT WAS URGED TO CALL THE HEALTHCARE PROVIDER (HCP) WITH ANY PROBLEMS ASSOCIATED WITH THE PROCEDURE. THE LAST ¿READING¿ OF THE PUMP WAS ON (B)(6) 2013. AT THIS TIME, THE DEVICE SYSTEM WAS USED TO DELIVER 10MG/ML AT 3.484MG/DAY OF HYDR OMORPHONE AND 1.6MCG/ML AT 0.5575MCG/DAY OF PRIALT. THERE WAS AN INCREASE FROM 3.629MG/DAY OF HYDROMORPHONE AND 0.5806/DAY OF PRIALT. THE PUMP LOGS WERE NOT READ. AT THE TIME OF THE REPORT, NO FUTURE APPOINTMENTS WERE SCHEDULED. THE REPORT SOURCE DID NOT SHOW A REFILL DONE ON (B)(6) 2013 AND WAS NOT AWARE OF A HOME INFUSION COMPANY BEING USED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PRIALT DOSE AS OF (B)(6) 2013 WAS 0.3419 MCG/DAY (0.014MCG/HOUR). IT WAS REPORTED THE PA TIENT¿S HEALTH CARE PROVIDER WAS NOT AWARE THAT THE PATIENT WAS ON XYREM. THE PATIENT¿S NEXT VISIT WAS ¿IN A COUPLE WEEKS¿. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65776 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O